Kenvue Brands LLC: Drug Recall

Recall #D-0121-2026 · 10/21/2025

Class II: Risk

Recall Details

Recall Number
D-0121-2026
Classification
Class II
Product Type
Drug
Recalling Firm
Kenvue Brands LLC
Status
Ongoing
Date Initiated
10/21/2025
Location
Summitt, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,816 bottles

Reason for Recall

Defective Container

Product Description

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.

Distribution Pattern

U.S. Nationwide - CO, IL, OH and IN.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.